Status:
COMPLETED
Assistive Soft Robotic Glove Intervention Using Brain-Computer Interface for Elderly Stroke Patients
Lead Sponsor:
National University Hospital, Singapore
Collaborating Sponsors:
National University of Singapore
Agency for Science, Technology and Research
Conditions:
Stroke
Eligibility:
All Genders
55-90 years
Phase:
NA
Brief Summary
This research aims to integrate and develop a novel Brain-Computer Interface (BCI) controlled soft robotic glove, evaluate the ability of the glove in achieving common hand grasping postures and to as...
Detailed Description
Hand motor impairment is very common after a stroke. These impairments include difficulty moving and coordinating the hands and fingers, which inhibits stroke patients from being able to perform daily...
Eligibility Criteria
Inclusion
- Aged 55-90 years regardless of lesion size, race
- History of stroke less than 3 months prior to participation
- Stroke type: ischemic or haemorrhagic
- Fugl-Meyer motor score (FM score) of upper extremity impairment of 0-45 out of a maximum score of 66 on the Fugl-Meyer assessment scale
- Ability to pay attention and maintain supported sitting for 1.5 hours continuously
- Lack of or poor hand mobility (Medical Research Council Grade ≤ 2/5)
- Able to give own consent
- Able to comprehend and follow commands (Abbreviated Mental Test equal or more than 7)
- Fulfil BCI resting brain states on initial screening.
- Unilateral upper limb impairment
Exclusion
- Recurrent clinical stroke
- Functional status: severe aphasia or inattention, unstable medical conditions which may affect participation (e.g. unresolved sepsis, postural hypotension) or anticipated life expectancy of \<1 year due to malignancy or neurodegenerative disorder)
- Hemispatial neglect (visual or sensory) or severe visual impairment despite visual aids
- History of severe depression or active psychiatric disorder
- Skull defect or previous cranial surgery as this would affect physical fit of EEG cap interface
- Local arm factors: severe spasticity Modified Ashworth scale \>1+ in any region, fixed joint contractures or joint replacements, patients with poor skin conditions which would contraindicate repetitive arm training, upper limb pain impeding movements with visual analogue scale (VAS score) \>4/10, other conditions ensuing upper limb weakness, skull defect, polydactyly or amputation of fingers, and allergy to electrodes or adhesive gel
Key Trial Info
Start Date :
March 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2019
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03277508
Start Date
March 2 2018
End Date
April 22 2019
Last Update
April 30 2019
Active Locations (1)
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1
National University Hospital
Singapore, Singapore, 119074